Browsing by Autor "Linder Figueroa"

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    Eficacia y seguridad en la nueva regulación de productos farmacéuticos en el Perú
    (National Institute of Health of Peru, 2012) Hans Vásquez; Sofia Noelia Sarmiento Salas; Linder Figueroa; Sonia Gutiérrez
    Internationally, pharmaceutical products (FP) are authorized after their risk-benefit profile has been assessed, taking into account efficacy, safety and quality parameters. In 2009, it was established in Peru that all pharmaceutical products to be commercialized should show proof of their efficacy and safety. According to the new regulation, in effect as of 2012, the pharmaceutical specialties (FS) have been grouped into three categories: category 1, if included in the National List of Essential Medicines; category 2, if authorized in countries with high health surveillance; and category 3, if not included in categories 1 or 2. The scientific documentation to be submitted for the registration or re-registration of the product in the regulatory entity will depend on its FS category.
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    Eficacia y seguridad en la nueva regulación de productos farmacéuticos en el Perú
    (National Institute of Health of Peru, 2014) Hans Vásquez; Sofía P. Salas; Linder Figueroa; Sonia Celedonia Huyhua Gutiérrez
    Internationally, pharmaceutical products (FP) are authorized after their risk-benefit profile has been assessed, taking into account efficacy, safety and quality parameters. In 2009, it was established in Peru that all pharmaceutical products to be commercialized should show proof of their efficacy and safety. According to the new regulation, in effect as of 2012, the pharmaceutical specialties (FS) have been grouped into three categories: category 1, if included in the National List of Essential Medicines; category 2, if authorized in countries with high health surveillance; and category 3, if not included in categories 1 or 2. The scientific documentation to be submitted for the registration or re-registration of the product in the regulatory entity will depend on its FS category.